FDA Issues 2020 Drug Safety Priorities Annual Report
The CDER Drug Safety Priorities 2020 report details CDER’s work to manage drug safety issues through modernized safety surveillance methods and innovative responses to safety concerns. The report highlights key safety-related milestones and accomplishments of 2020, as well as the many ways in which CDER has been involved in promoting and protecting public health during the SARS-CoV-2 coronavirus (COVID-19) pandemic. The report focuses on the programs and initiatives at the core of CDER’s drug safety operations, including the FDA Adverse Event Reporting System, the Sentinel System, and the Safe Use Initiative. It also features ongoing activities to address the national opioid crisis, work in addressing unexpected – and potentially cancer-causing – impurities in medicines, use of a broad range of communications tools and technologies such as Drug Safety Communications to transparently communicate drug safety to the public, and research being conducted CDER-wide to better understand drug safety risks.
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